Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

This study has been completed.
Information provided by:
Ipsen Identifier:
First received: October 5, 2005
Last updated: June 26, 2008
Last verified: June 2008
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide

Condition Phase
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months

Secondary Outcome Measures:
  • Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
  • Risk in each of the 4 valves at 6 & 12 months
  • Risk of significant regurgitation in each valve at 6 & 12 months
  • Prevalence of valvular regurgitation at baseline
  • Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months

Estimated Enrollment: 200
Study Start Date: May 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has a diagnosis of Acromegaly
  • Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
  • Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
  • Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study

Exclusion Criteria:

  • Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
  • Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
  • Patients who have received treatment with a GH antagonist for more than 3 months
  • Patients who have had heart valve replacement therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00234520

  Show 33 Study Locations
Sponsors and Collaborators
Study Director: France Catus, MD Ipsen
  More Information

Publications: Identifier: NCT00234520     History of Changes
Other Study ID Numbers: 2-47-52030-721
Study First Received: October 5, 2005
Last Updated: June 26, 2008

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 23, 2017